PERSONAL CARE ANTIBACTERIAL DEODORANT- chloroxylenol soap
Delta Brands & Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Chloroxylenol 0.1%

Purpose

Antibacterial

Use

■for hand washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

■avoid contact with eyes. In case of eye contact, flush with water

Stop use and ask a doctor if

■irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Inactive ingredients

Sodium Palmate, Sodium Tallowate, Sodium Cocoate, Sodium Palm Kernelate, Water, Glycerin, Fragrance,Sodium Chloride, Tetrasodium EDTA, FD&C Yellow No. 6, FD&C Yellow No. 5

Package Label

PERSONAL CARE ANTIBACTERIAL DEODORANT
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72133-048
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMITATE (UNII: JQ43KP6296)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72133-048-02	85 g in 1 BOX; Type 0: Not a Combination Product	04/05/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/05/2018

Labeler - Delta Brands & Products LLC (080999173)